In Applicant's above-referenced and incorporated co-pending application for U.S. patent, novel apparatus and methodology are disclosed for examining, and appraising the physiological state or condition of biological tissue; in particular, for conducting in vivo examination and assessment of the physiological state of human tissue, for example diagnostic breast (or other) examination of live human subjects.
In accordance with the referenced methodology and apparatus, selected light spectra are introduced into the subject being examined at a first location, and the light energy so infused is then received (e.g., detected) at other particular locations, preferably including both a "near" and "far" such location, for example, near the point of light infusion and generally opposite that point. As described in the referenced co-pending application, the distances between the point of initial light insertion and the points of light reception are important factors in the useful application of the "raw" data (i.e., the particular measured values of the detected light energy). In the referenced application, a vernier-like scale is incorporated in the "optical probe", whereby the particular distance between the two optical "heads" (i.e., the light-producing and the light-receiving instrumentalities) may be determined in any given position to which the two such heads are adjusted to accommodate the size of a particular subject of examination. Such distance determinations, which may be designated "nominal optical distances", were then inputted into the computing apparatus utilized for resolving the data, via the computer control keyboard.
The "optical heads" or components illustrated in the referenced co-pending application basically comprise a light-injection terminal (e.g., the end of a fiber optic bundle or cable), coupled back to a light source (as through the fiber optic cable itself), together with an arrangement of light detector elements, e.g., photovoltaic cells, or photosensors, whose electrical outputs are coupled back to the processing apparatus (e.g., computer) by electrical conductors which extend, with the aforementioned fiber optic cable, from the hand instrument or optical probe to the cabinet which houses a computer, light-generation means, and other apparatus involved. In the embodiment shown in the referenced disclosure, the light-detectors are in effect hooded, being disposed in recessed areas, with optical masks and/or filter elements locatable between the detectors themselves and the subject from which data is to be obtained.
The apparatus in the referenced disclosure, while operative and useful, nonetheless had various features and attributes which were less than completely desirable. For example, the optical probe apparatus was somewhat heavy, as well as somewhat cumbersome; also, the distance-determining means, as noted above, was somewhat rudimentary and susceptible of imprecision, involving the requirement for visual determination together with the need for extra manipulative activity to manually input the data into the computer, both such operations having attendant error-introduction possibilities. Furthermore, as noted above, the referenced apparatus included multiple individual detectors at the optical heads, for multiple data sampling, from different specific locations, permitting extensive analytical processing, through digital computing techniques, and for enhanced accuracy through substantial elimination of spurious or missing data samples.